Regulatory Affairs Specialist Africa

About the role

The Regulatory Affairs Specialist develops and executes regulatory strategies to obtain and maintain medical device registrations across African markets. The role supports business growth by ensuring compliance with local requirements and facilitating timely market access for a range of medical devices.

Key responsibilities

• Prepare, compile and submit registration dossiers, manage renewals, amendments and change notifications for Class I‑IV medical devices across multiple African jurisdictions.
• Maintain up‑to‑date knowledge of global and African regulatory requirements and ensure company practices align with standards such as ISO 13485 and MDR/IVDR.
• Act as primary contact with national authorities, notified bodies, local representatives and distributors, handling queries, deficiency letters and audit interactions.
• Monitor regulatory intelligence, communicate changes to senior management and represent the company in industry forums and working groups.

Required profile

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs or a related scientific discipline (advanced degree or certification is a plus).
• 3‑7 years of regulatory affairs experience in the medical‑device industry, with proven success managing registrations in several African markets.
• In‑depth knowledge of African medical‑device regulatory frameworks and familiarity with ISO 13485, ISO 14971, MDR/IVDR and GMDN.

Required skills

• Preparation of regulatory documentation and technical files.
• Knowledge of ISO 13485 and ISO 14971 standards.
• Understanding of MDR/IVDR principles and Global Medical Device Nomenclature (GMDN).
• Experience communicating with notified bodies and competent authorities.
• Change‑assessment for impacts on EMEA‑region registrations.